Abstract
Objective Oral glucocorticoids (OGCs), antimalarials and immunosuppressants are the mainstay of SLE treatment; however, cumulative OGC use is associated with increased risk of organ damage. Thus, OGC dose reduction or complete withdrawal with the attainment of remission (measured by the Definition Of Remission In SLE, DORIS) or low disease activity (LDA, measured by Lupus Low Disease Activity State, LLDAS) are important treatment goals in SLE. Steroid-sparing effects of intravenous (IV) belimumab were demonstrated in previous studies, but long-term, real-world data on belimumab’s effect on clinical outcomes are limited. This study assessed the effect of up to 24 months of belimumab treatment on OGC dose reduction, combined with disease activity measures, in patients with SLE in the US.
Methods This descriptive post hoc analysis (GSK Study 219649) of OBSErve study data captured clinician-reported data for adults with SLE in US rheumatology practices with ≥6 months of documented medical history before belimumab initiation (index) who received ≥8 infusions of belimumab 10 mg/kg IV. Primary outcome: proportion of patients achieving OGC dose of ≤10 mg/day, ≤7.5 mg/day, ≤5 mg/day or 0 mg/day at 6, 12, 18 or 24 months post-index. Secondary outcomes: proportion of patients maintaining their 6-month post-index daily OGC dose threshold; proportion of patients achieving modified LLDAS (SLE Disease Activity Index [SLEDAI] score ≤4 with no worsening of clinical manifestations and OGC dose ≤7.5 mg/day) or modified remission (SLEDAI score 0 and OGC dose ≤5 mg/day) over time.
Results Overall, 501 patients were included. Of those with a known OGC dose, the proportion receiving lower doses (≤10 mg/day, ≤7.5 mg/day, ≤5 mg/day and 0 mg/day) increased over time, as did the proportion maintaining low OGC dose thresholds from 6 to 24 months post-index (except for 0 mg/day; table 1). The proportion of patients achieving LDA and remission generally increased over time (table 2).
Conclusions These results demonstrate the sustained steroid-sparing effect of long-term belimumab treatment, along with the ability to attain LDA and remission in patients with SLE in US clinical practices.
Acknowledgements This study was funded by GSK.
